A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00540618
First received: October 4, 2007
Last updated: November 27, 2007
Last verified: November 2007
  Purpose

To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.


Condition Intervention Phase
Plaque Psoriasis
Drug: MEDI-507
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) [ Time Frame: Days 14, 28, 42, 56, 70, 91, 107, and 167 ]

Secondary Outcome Measures:
  • Observe adverse and serious adverse events [ Time Frame: Day 107 and 167 ]

Enrollment: 420
Study Start Date: September 2001
Study Completion Date: July 2003
Arms Assigned Interventions
Active Comparator: 1
MEDI-507
Drug: MEDI-507
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
Placebo Comparator: 2 Other: Placebo
Active Comparator: 3
MEDI-507
Drug: MEDI-507
Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
Active Comparator: 4
MEDI-507
Drug: MEDI-507
Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)

Detailed Description:

The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plaque psoriasis involving at least 10% of body surface area
  • Age 18 through 65 years at the time of the first dose of study drug
  • Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue
  • Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)
  • Written informed consent obtained from the patient
  • Ability to complete follow-up period of 167 days as required by the protocol

Exclusion Criteria:

  • Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
  • PASI score <8
  • At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal
  • At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection
  • Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
  • History of cancer (except excision of basal cell carcinoma)
  • Any documented immunodeficiency
  • A history of prior administration of monoclonal antibodies or related proteins
  • Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks
  • Use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor)
  • Receipt of any investigational drug therapy within 6 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted)
  • Current or planned participation in a research protocol in which an investigational agent or therapy may be administered
  • Nursing mother
  • Acute illness including infections 15. Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540618

  Show 43 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Christine A Dingivan, M.D. MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00540618     History of Changes
Other Study ID Numbers: MI-CP082
Study First Received: October 4, 2007
Last Updated: November 27, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014